In medical practice, it is often desirable and necessary to provide means for instilling material into or aspirating material from the body of a patient. As is commonly known, hypodermic needles serve these functions adequately for those portions of the human body which are relatively solid, such as bone and muscle mass. However, the human body contains many natural voids such as the stomach and intestines, blood vessels, lungs, bladders and so forth, for which, for example, hypodermic needles are typically unsatisfactory as means for instilling or aspirating materials.
It is often necessary to cleanse these natural voids, or to remove or replace the fluid or material found therein. For example, it is not uncommon for an individual to unintentionally ingest undesirable or even toxic substances into the stomach. These substances, along with any other materials thereby contaminated, must be removed from the stomach and the stomach cleansed. This is typically accomplished by a lavage apparatus capable of instilling material and aspirating material directly to and from the stomach.
To meet the substantially higher mass flow requirements of material flow needed to medically service the natural voids of the body, apparatus including body-insertable tubes of substantially greater diameter than the typical hypodermic needle are commonly employed. These tubes are typically provided with a distal end insertable through either a natural opening in the body, such as the nasal, oral or anal opening, or insertable through an artificial opening or incision in the body. The distal end is then directed to the desired disposition in the body as required by the particular medical considerations. A proximate end of the tube remains outside the body where the medical personnel may conveniently perform the desired operations with the tube.
An axial passage or primary lumen extends through the tube member from at or near the distal end portion to the proximate end for communicating material through the lavage apparatus and thereby into and out of the body void. One or more secondary lumens intersect the primary lumen and permit material communication, through the distal end portion between the primary lumen and the concerned body void. The disposition of these lumens is most important, since the secondary lumens permit the actual material flow and obstruction thereof can inhibit or prevent the necessary material flow.
A number of difficulties have arisen in connection with the use of such tubes, however. Since the tubes are of relatively large diameter and the internal body tissues are typically relatively fragile and delicate, such a tube must present an exterior surface which is designed to minimize incidental damage to internal body tissue. Furthermore, the body cannula through which such tubes are inserted are not linear, and such a tube must be of sufficient flexibility to enable it to follow the contours of such body cannula as the esophagus or the intestines, while retaining sufficient rigidity to enable the medical personnel inserting the tube to direct the tube appropriately within the body.
It is also typically desirable to minimize the transfer of body fluids from one location in the body to another in order to minimize the risk of infection and subsequent distress to the patient. For example, if the distal end of the lavage apparatus permits the accumulation of fluids in the primary lumen or in a cavity on the exterior surface of the distal end, the accumulated fluids enable rapid reproduction of undesired bacterial or viral agents. Also, toxic or even otherwise harmless fluids so accumulated on the exterior surface of the distal end, such as those commonly found in the stomach, may enter other portions of the body in which such fluids represent a hazard, such as subcutaneous body tissues and muscle, when the lavage apparatus is removed, especially through an incision.
An additional substantial difficulty lies in the fact that the distal end of such a tube is not visible to the medical personnel after initial insertion into the body. The personnel emplacing the tube can experience great difficulty in determining the actual location of the distal end of the tube within the body. While knowledge of the exact location of the distal end of the tube is not critical in all cases, the proper disposition of the distal end is necessary in many cases to ensure that the necessary medical operations are properly completed.
A number of attempts have been made to alleviate these problems. For example, the distal end of such tubes are often provided with a tip member or other closure member to assist in properly guiding the tube. This tip member is typically designed to aid in the directing of the tube within the body. However, both the tip member and the tube are typically flexible and an annular cavity may form at the junction of the tube and the tip member, which permits the undesirable transfer of body fluids. Furthermore, the relative flexing of the tube and tip member can interfere with the bonding of the tip member to the tube, which may permit the tip member to detach within the body so as to pose a serious health risk to the patient. Some tubes are further provided with a radiopaque tip member at the distal end of a tube, which permits the medical personnel to determine the general disposition of the distal end of the tube member within the body by radiological techniques. However, internal body features appear at differing degrees of radiopaqueness and can mislead the medical personnel as to the actual placement of the distal end.
In order to overcome the problem of tip member detachment, other apparatus have been provided which include a tube member having an integrally formed tip member. This avoids the risk of detachment but prevents the use of a tip member having a flexibility different than that of the tube member and reduces the guidability of the tube member within the body. Such a solution also prevents the use of a tip member having a radiopaqueness different from the tube. Other proposed solutions have included other means of bonding the tip member to the tube to produce a one-piece assembly from the tip member and tube components. Such solutions often are substantially more expensive and time-consuming to manufacture, with the result that the tubes so produced are substantially more expensive.
It is therefore an object of the present invention to provide such a lavage apparatus as is readily guidable in the human body.
It is a further object of the present invention to provide such a lavage apparatus as will include means for permitting accurate radiopaque observation of the disposition thereof in the human body.
It is yet a further object of the present invention to provide such a lavage apparatus as will include means for permitting accurate radiopaque observation of the disposition of the secondary lumens.
It is another object of the present invention to provide such a lavage apparatus as will prevent the undesirable accumulation of fluids in or on the distal end portion thereof.
It is yet another object of the present invention to provide such a lavage apparatus as may employ a tip member having a differing degree of flexibility than that of other portions of the lavage apparatus.
It is yet another object of the present invention to provide such a lavage apparatus as having exactly marked distances from the distal tip to enable the operator to know precisely where placement may occur.
Yet another object of the invention is to have and provide a lavage tube that cooperates with a fitting that will allow both delivery and aspiration of lavage fluid or stomach contents in such a way as to prevent the lavage tube from becoming separated from the delivery device (e.g., syringe).
Yet another further object of the invention is to provide such a lavage tube working/insert end assembly, including tip, perforated tube portion and non-perforated tube portion wherein the durometer measure of the tip material, tube portion with perforations or holes therethrough and following non-perforated tube portion causes the tip and following perforated tube portion of the lavage tube to follow the greater curve of the mouth/throat rear wall whereby to avoid this tube entering the bronchial tube.
These and other objectives of the present invention will become apparent in the specification and claims that follow.